1. CE CERTIFICATE OF CONFORMITY
WITH EUROPEAN DIRECTIVE
®
Certificate No.:
Order No.:
Nemko
1112409
194498
We hereby certify that an examination has been carried out following the requirements of the national
legislation “Regulation no. 1690 of l5 December 2005 relating to medical devices pursuant to act no. 6
th
of 1 2 January 1995 relating to medical devices, transposing directive 93/42/EEC into Norwegian law to
which the undersigned is subjected, confer EEA agreement, proposition no. 100 (1991 -92) special
appendix no. 2, volume 2A13 A, goods, chapter XXX”. We certify that the production quality system
conforms to the relevant provisions of the Annex given below:
Name and address of the
manufacturer:
Zynex Medical, Inc.,
9990 Park Meadows Dr.,.
Lone Tree, CO 80124
USA
Device category:
Electro-therapy device
GMDN code:
46573
Models:
See Appendix 1 to this certificate
Risk class as defined by the
manufacturer:
Ila
Standards/provisions:
The audit of the quality system was based upon and assessed according
to the provisions in Annex II of the EC-Directive 93/42/EEC, with the
exemption of section 4.
Date of audit:
2011-12-07
Date of the end of the
validity:
2017-01-01
Nemko EC notification No.:
0470
On this basis the manufacturer or the European authorised representative may draw up an EC I EEA
Declaration of Conformity and affix the CE-marking as indicated below together with the Nemko EC
notification number to each conforming product as long as the conformity audit and inspection procedure
required by the EC directive will be fulfilled by the manufacturer and the factory. The product liability rests
with the manufacturer or his representative in accordance with Council Directive 85/374/EEC.
Date of issue: 2011-12-20
Signature:
Frank Skarpsno
Lead auditor/Principal Engineer
Nemko AS
P.O. Box 73, Blindern
N-0314 Oslo, Norway
Office address
Gaustadalleen 30
Oslo
Date of verification: 2011-12-20
Signature: Arild
R. Hansgãrd
Lead auditor/Principal Engineer
Internet
www.nemko.com
Telephone
+47 22 96 03 30
Enterprise number:
Fax
+47 22 960 550
NO 9443522430

2. CE CERTIFICATE OF CONFORMITY
WITH EUROPEAN DIRECTIVE
® Nemko
Certificate No.:
Order No.:
Manufacturer:
Zynex Medical, Inc.,
9990 Park Meadows Dr.,.
Lone Tree, CO 80124
USA
Device category:
1112409
194498
Electro-therapy device
Appendix 1: Page 1 of 1.
The certificate referred to above includes the followinQ device/model:
NexWave
Date of issue: 2011-12-20
s,gnatwe:
Frank Skarpsno
Date of verification: 2011-12-20
Signature: Arild
Lead auditor/Principal Engineer
Nernko AS
P.O. Box 73, Blindern
N-0314 Oslo, Norway
Office address
Gaustadalléen 30
Oslo
R. Hansgãrd”
Lead auditor! Principal Engineer
Internet
www.nemko.com
Telephone
÷47 22 96 03 30
Enterprise number:
Fax
+47 22 960 550
NO 9443522430